A Phase I Trial Assessing the Safety and Feasibility of Prophylactic Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Immediate Reconstruction in Patients With In-Situ or Invasive Breast Cancer
18 Years
N/A
Female
Breast Cancer, Ductal Carcinoma
Trial Information
A Phase I Trial Assessing the Safety and Feasibility of Prophylactic Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Immediate Reconstruction in Patients With In-Situ or Invasive Breast Cancer
- The use of NAC-sparing mastectomy followed by postoperative NAC (nipple-areola complex)
external beam radiotherapy for selected patient with early stage invasive or in-situ
breast cancers will be technically feasible and with acceptable complication rates.
- The cosmetic results after NAC-sparing mastectomy followed by postoperative external
beam radiotherapy to the NAC will be better comparable with Skin Sparing Mastectomy.
- The local control rate in the NAC will be more than expected for a NAC sparing
mastectomy without postoperative radiotherapy.
- The patient's satisfaction after NAC-sparing mastectomy followed by postoperative NAC
external beam radiotherapy will be better than after Skin Sparing Mastectomy.
Inclusion Criteria:
- Patients must have histologically confirmed in-situ or invasive breast carcinoma.
- Tis, T1, T2 invasive or non-invasive carcinoma of the breast; lesion less than 4 cm.
- Unifocal, multifocal or multicentric breast cancers that can be removed by nipple
sparing mastectomy with negative margins.
- Negative surgical margins.
- No extensive intraductal component or patient with distant metastases.
- Patients must be > 18 years of age.
- No concomitant or history of nipple discharge or skin involvement.
- No prior history of malignancy (less than 5 years prior to study entry), except
non-melanomatous skin cancer.
- No prior history of radiation to the chest.
- No collagenous disease (systemic lupus erythematosis, scleroderma, dermatomyositis)No
previous non-hormonal therapy including radiation or chemotherapy for current breast
cancer.
- No patients with Paget's disease of the nipple.
- No patients with co-existing medical conditions with life expectancy < 2 years.
- No pregnant or lactating women.
- ECOG 0 - 2.
- Signed study-specific informed consent form prior to the study entry.
Exclusion Criteria:
- Retroareolar breast cancer lesions.
- Concomitant or history of nipple discharge or skin involvement.
- Patient with distant metastases.
- Patient with extensive intraductal carcinoma.
- Any previously irradiated ipsilateral breast cancer.
- Patients with Paget's disease of the nipple.
- Patients with collagenous diseases, as systemic lupus erythematosis, scleroderma or
dermatomyosis.
- Other malignancy, except non-melanomatous skin cancer, less than 5 years prior to
participation in this study.
- Patients who are pregnant or lactating due to potential exposure of the fetus to RT
and unknown effects of RT to lactating females.
- Patients with BRCA 1-2 mutations.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the recommended phase II dose of post-operative prophylactic NAC irradiation.
Outcome Description:
The recommended phase II dose will be the highest irradiation dose level at which <= 1 out of 6 study patients experiences dose-limiting toxicity (DLT). This dose will be the phase dose II of post-operative prophylactic NAC irradiation after NAC-sparing mastectomy with reconstruction in patients with ductal carcinoma in-situ or invasive breast cancer.
Outcome Time Frame:
2 to 3 Years
Safety Issue:
Yes
Principal Investigator
Cristiane Takita, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Miami Sylvester Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
EPROST-20090299
NCT ID:
NCT01208974
Start Date:
October 2009
Completion Date:
Related Keywords:
- Breast Cancer
- Ductal Carcinoma
- Breast Cancer
- Nipple Area Complex
- Mastectomy
- Radiation Therapy
- Nipple-Sparing
- Breast Reconstruction
- Breast Neoplasms
- Carcinoma
- Carcinoma, Ductal, Breast
- Carcinoma, Ductal
Name | Location |
|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
